- Males or females 17 years or older with confirmed closure of the tibial epiphyses,
with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked
IM nailing procedure and the absence of an associated compartment syndrome or vascular
injury;
- Closed tibial fractures Types A, B & C (See OTA fracture classification) can be
included.
- Previous fractures of the same tibia that may impact nailing procedure or impaired
visibility of current fracture or a history of osteomyelitis;
- Subjects with any other clinically significant injuries, which may significantly
impair weight bearing of the affected limb;
- Subjects with a fracture gap of >1cm after initial surgery and prior to drug
administration;
- Any other planned invasive or non invasive interventions intended to promote bone
healing of the tibial fracture under study are not allowed in the first 24 weeks after
treatment.